FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
153625–153648 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 1984
PLT - 4 PLATELET
K840302 · JPK
R&D Systems, Inc.
Hematology · 48d
Cleared Mar 12, 1984
CATEGORY 2 GEN. HOSPITAL & PERSONAL USE
K840306 · HTD
Imm Enterprises , Ltd.
General & Plastic Surgery · 48d
Cleared Mar 12, 1984
CAT. 3 GASTROENTEROLOGY-UROLOGY DEV
K840307 · HTD
Imm Enterprises , Ltd.
General & Plastic Surgery · 48d
Cleared Mar 12, 1984
CAT. 5-RADIOLOGY DEVICES
K840309 · HTD
Imm Enterprises , Ltd.
General & Plastic Surgery · 48d
Cleared Mar 12, 1984
CAT 11- GENERAL & PLASTIC SURGERY DEV
K840315 · HTD
Imm Enterprises , Ltd.
General & Plastic Surgery · 48d
Cleared Mar 12, 1984
CAT 12-ORTHOPEDIC & REHAB DEVICE
K840316 · HTD
Imm Enterprises , Ltd.
General & Plastic Surgery · 48d
Cleared Mar 12, 1984
CAT 13-CLINICAL CHEMISTRY DEVICES
K840317 · HTD
Imm Enterprises , Ltd.
General & Plastic Surgery · 48d
Cleared Mar 12, 1984
CAT 15-HEMATOLOGY & PATHOLOGY DEVICE
K840319 · HTD
Imm Enterprises , Ltd.
Hematology · 48d
Cleared Mar 12, 1984
CAT. 16-IMMUNOLOGY DEVICES
K840320 · HTD
Imm Enterprises , Ltd.
Immunology · 48d
Cleared Mar 12, 1984
MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE
K840354 · FCG
Sherwood Medical Co.
Gastroenterology & Urology · 46d
Cleared Mar 12, 1984
BIOPSY NEEDLES VARIOUS
K840401
E-Z-Em, Inc.
General & Plastic Surgery · 41d
Cleared Mar 12, 1984
VENA * BRIDGE
K840403
Neward Enterprises, Inc.
Physical Medicine · 41d
Cleared Mar 12, 1984
ULNAR NERVE PROTECTOR
K840421 · FWZ
Devon Industries, Inc.
General & Plastic Surgery · 41d
Cleared Mar 12, 1984
DEVON HEAD REST
K840422 · FWZ
Devon Industries, Inc.
General & Plastic Surgery · 41d
Cleared Mar 12, 1984
TISSUE EXPANDER
K840464 · LCJ
Surgitek
General & Plastic Surgery · 38d
Cleared Mar 12, 1984
SURGISCRIBE MARKING PEN
K840470 · FZZ
Surgicot, Inc.
General & Plastic Surgery · 38d
Cleared Mar 12, 1984
TOTAL IRON UIBC/TIBC ASSAY
K840485 · CFM
Somas Medical Industries, Inc.
Chemistry · 35d
Cleared Mar 12, 1984
T-METER
K840487 · HCS
K.J. Electronics
Neurology · 35d
Cleared Mar 12, 1984
DISPOSIQUET A DISPOS. TOURNIQUET
K840489 · GAX
Med Lab Products
General & Plastic Surgery · 35d
Cleared Mar 12, 1984
STEIGER TUNNELING INSTRUMENT 285
K840529 · DRC
Evermed, Inc.
Cardiovascular · 33d
Cleared Mar 12, 1984
MOLE-MARKER
K840651 · FTY
Notation Systems, Inc.
General & Plastic Surgery · 26d
Cleared Mar 12, 1984
TRACHEOSTOMY CLEANING TRAY
K840664 · BSY
American Pharmaseal Div. Ahsc
Anesthesiology · 26d
Cleared Mar 12, 1984
CARDIAC CATHETERIZATION PACK
K840671 · DRE
Professional Medical Services
Cardiovascular · 20d
Cleared Mar 12, 1984
SENSIBEAD EIA DIGOXIN KIT
K840673 · KXT
Terumo Medical Corp.
Chemistry · 26d